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Treximet in Acute Migraine Headache: Assessing Cognitive Function

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Neurological Research Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Neurological Research Center
ClinicalTrials.gov Identifier:
NCT00837044
First received: February 4, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  Purpose

Migraine headache occurs frequently in women more than men and is associated with symptoms not only of significant pain but also of symptoms typically including of photophobia, phonophobia, nausea and vomiting. Many migraine patients report difficulty in cognition from lack of concentration, difficulty in word finding or inability to remember. Many of these cognitive symptoms seem to be independent of the pain intensity and may occur completely separately from the headache pain but can be disabling. It is likely that the frequency and importance of cognitive symptoms associated with migraine are underreported.

The Mental Efficacy Workload Test (MEWT) is a computerized battery that is designed to be an efficient and accurate measure of cognition during migraine headache. Treximet is a new migraine treatment recently FDA approved for the treatment for the relief of acute migraine that may be effective for the cognitive symptoms for migraine patients who have a history of cognitive dysfunction during a migraine headache. The primary efficacy parameter is to evaluate the effectiveness of treatment with Treximet versus placebo in patients with acute migraine headache measuring neuropsychological function using the MEWT during the migraine and comparing that score with a prior MEWT score when the patient had no migraine symptoms. A double blind, placebo-controlled, crossover study was chosen so that each patient may be her or his own control.

It is the intent of this study to determine the type and intensity of cognitive dysfunction associated with migraine headache and to what extent that Treximet may relieve the cognitive dysfunction in a safe and effective manner.


Condition Intervention
Migraine Headache
Cognitive Impairment
Drug: Treximet
Drug: Migraine rescue medication of choice

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: An Evaluation of Treximet in the Treatment of Acute Migraine Headache: A Placebo-Controlled, Double-Blind, Crossover Study, Assessing Cognitive Function.

Resource links provided by NLM:


Further study details as provided by Neurological Research Center:

Primary Outcome Measures:
  • To evaluate the effectiveness of treatment with Treximet versus placebo in patients with acute migraine headache on the neuropsychological function before treatment and at one and two hours after treatment of a migraine. [ Time Frame: 2 hours post dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess incidence and types of neuropsychological deficits by MEWT in patients with acute migraine headache before treatment. [ Time Frame: 2 hours post dose ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: February 2009
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Treximet, cognitive testing
Drug: Treximet
Treximet
Other Name: Sumatriptan succinate 85mg/Naproxen Sodium 500mg
Placebo Comparator: 2
Placebo, Cognitive testing
Drug: Migraine rescue medication of choice
Migraine rescue medication of choice

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Females and male subjects, ages 18-65 inclusive
  2. Have migraines with or without aura as expressed by the International Headache Society (IHS) criteria for at least six months and at least one attack per month for three months prior to screening
  3. If female, have an acceptable method of contraception during the study, have no plans to become pregnant and have a negative urine pregnancy test at screening and throughout the study.
  4. Must be able to follow study protocol including all neuropsychological testing, MEWT assessments and evaluation forms.
  5. Must be willing and able to provide written informed consent

Exclusion Criteria:

  1. Have more than 15 headache days per month
  2. Have hemiplegic or secondary headaches
  3. Have significant risk factors for cardiovascular or cerebrovascular disease as assessed by the investigator
  4. Are taking any medication that is contraindicated with a triptan or NSAIDs
  5. Have any significant concomitant disease
  6. Have any allergy to triptans, aspirin or NSAIDs
  7. Have a history of substance abuse, psychiatric illness in the last 5 years
  8. Are participating or have participated in an investigational drug trial within the last 30 days
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00837044

Contacts
Contact: Judith R Button, BS/CRC 802-447-7577 ext 104 jbutton@tristateneuro.com
Contact: Carol L Gorman, LPN/CCRC 802-447-7577 ext 108 cgorman@tristateneuro.com

Locations
United States, Vermont
The Neurological Research center, Inc Recruiting
Bennington, Vermont, United States, 05201`
Principal Investigator: Keith R Edwards, MD         
Sponsors and Collaborators
Neurological Research Center
GlaxoSmithKline
Investigators
Principal Investigator: Keith R Edwards, M.D. The Neurological Research Center, Inc.
  More Information

Publications:
Ardila A, Sanchez F. Neuropsychological symptoms in the migraine syndrome. Cephalalgia 1988; 8: 67-70
Farmer K, Cady R, Reeves D, Bleiberg J. Cognitive efficiency following migraine therapy. In: J. Olsen, T.J. Steiner, R.B. Lipton (Eds.) Reducing the burden of headache: Frontiers in headache research (pp 46-51) New York: Oxford University Press 2003

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Keith R. Edwards, M.D., The Neurological Research Center, Inc
ClinicalTrials.gov Identifier: NCT00837044     History of Changes
Other Study ID Numbers: 112488
Study First Received: February 4, 2009
Last Updated: February 4, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cognition Disorders
Headache
Migraine Disorders
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Headache Disorders
Headache Disorders, Primary
Mental Disorders
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on November 20, 2014